Vivos Inc (RDGL)

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How does the FDA Decide Whether to Grant a Breakthrough Device Designation Request?

What is the FDA guidance on breakthrough device designations? The FDA has a rigorous process to ensure the safety and efficacy of medical breakthroughs, including a thorough review of applications of breakthrough technologies. The FDA looks at the scientific data and patient outcomes when submitting an application that weighs potential advantages over existing treatments available to patients. A breakthrough device designation carries with it special priority reviews, intense guidance, and urgency when remediating any issues. Through the Breakthrough Devices Program, the FDA can grant designations for those devices that can offer significant improvement compared to existing treatment options for individuals in need – ensuring each patient receives the best care possible.

FDA breakthrough device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis